SPIROMAC SPIROmetry to Manage Asthma in Children

Asthma affects 1.1 million children in the UK. When asthma attacks occur, they are frightening for children and their families. Every twenty minutes a child is admitted to hospital in the UK due to an asthma attack. Doctors think that that recent asthma symptoms should guide treatment choices to prevent attacks. However, doctors need a reliable test to measure how well children's lungs are functioning to be used alongside symptoms to guide treatment and reduce the number of asthma attacks. Lung function is important because it measures how easy it is to move air into and out of the lungs. Spirometry measures lung function. Children do spirometry by taking a big breath in and breathing out through a tube as hard as they can. The amount of air they can breathe out in the first second is called the FEV1 (forced expiratory volume in one second). Currently, doctors disagree about how to best use spirometry to monitor asthma because of a lack of research evidence and conflicting guidance from experts. We know that about 25% of hospital doctors in the UK use spirometry regularly in their asthma clinics. Our recent research shows that a change in FEV1 over a three-month period is followed with what parents tell us is a meaningful increased risk of an asthma attack in the next three months. We think that using spirometry to guide treatment will lead to reduced attacks. Our study is designed to test this. Our study will also explore the link between treatment guided by spirometry and symptoms, and the number of attacks. We will recruit 550 children aged six to 15 years with asthma who have had an asthma attack in the last year. All children will meet the research team at the hospital or at a family doctor's premises every three months (this interval is commonly used in hospital asthma clinics). At the first meeting, permission to take part in the study will be obtained. Everyone that takes part has an equal chance of getting either treatment guided by spirometry plus symptoms or symptoms alone (our control group). For all children, a computer programme will guide treatment decisions based on their current symptoms and treatment. But in the spirometry-guided group the computer programme will also use spirometry measurements. All children will have spirometry measured at every visit so we can better understand the relationship between lung function, asthma symptoms, changes in treatment and asthma attacks. We will collect asthma symptoms and details of any attacks from questionnaires which are completed at hospital clinic visits. At three-month intervals over a year, children will meet the research team, complete the symptom questionnaire and spirometry and have their treatment changed according to symptoms and spirometry or symptoms alone. We will measure asthma attacks and other outcomes over 12 months. We already have a network of recruiting centres and have identified asthma clinics in hospitals and general practices who will recruit participants. In partnership with Asthma UK we have discussed study design with parents and young people. They have told us what is a meaningful reduced risk for asthma attacks (i.e. 30%). Parents and young people have also contributed to this plain English summary. We will write a report which gives all our results. Our report will be published in a medical journal, given to the NHS, to participants and asthma guideline groups around the world.